NCT01596335已完成3 期
To Evaluate the Efficacy and Safety of TA-650 in Comparison With a Control Drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in Patients With Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin (IVIG).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 8
- 主要终点
- Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease.
- •Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight).
- •Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment.
- •Patients to whom the study drug can be administered by day 8 of disease.
排除标准
- •Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment.
- •Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization.
- •Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections.
- •Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B.
- •Patients confirmed to have HIV infection, or patients with a family history of HIV infection.
- •Patients who have a history of receiving treatment with infliximab or other biological products.
- •Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.
研究组 & 干预措施
TA-650
Experimental
干预措施: TA-650 (Drug)
VGIH
Active Comparator
干预措施: Polyethylene Glycol-treated Human Immunoglobulin (VGIH) (Drug)
结局指标
主要结局
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
时间窗: Up to 48hours
次要结局
- Incidence of Coronary Artery Lesions(Day 3, Day 7, Day14, Day 21, Day56)
- Duration of Fever(Up to Day56)
研究者
研究点 (8)
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